Eli Lilly and Co

The FDA released a draft guidance on multiregional clinical trials (MRCTs) in oncology, emphasizing that results must be interpretable to US patients. The guidance addresses issues raised during the review of Innovent Biologics and Eli Lilly’s cancer therapy Tyvyt, which was not approved in the US. The FDA advises sponsors to consider specific patient factors and socio-cultural influences, ensuring MRCT data supports a robust assessment of safety and effectiveness in US patients.

Eli Lilly's Q2 revenue surged 36% due to new product launches, but faces supply constraints and a 31% decline in Trulicity revenue. The company's financial health is strong with a 90% increase in operating income, but R&D expenses rose 15%. Eli Lilly's innovative pipeline and strategic acquisitions offer growth opportunities, despite high P/E ratio of 111.1x.

FDA approves Kisqali, a CDK4/6 inhibitor by Novartis, for early-stage breast cancer, expanding its use to include stage 2 and 3 HR positive, HER2 negative patients without positive lymph nodes. Kisqali, combined with hormone therapy, aims to reduce recurrence risk by 28.5% over endocrine therapy alone, as shown in the NATALEE trial. Common side effects include low white blood cell counts and joint pain, and it is administered for three years post-surgery.

Eli Lilly’s 177Lu-PNT2002, compared to ARPIs like Xtandi and Zytiga, showed efficacy in mCRPC patients positive for PSMA at ESMO 2024. Despite initial negative OS results, crossover adjustments led to a favorable HR of 0.68, likely influencing FDA approval. 177Lu-PNT2002, with lower dosage and fewer cycles than Pluvicto, may challenge Novartis’s market position.

Novo Nordisk, Roche, and Terns Pharmaceuticals presented data on their oral obesity candidates at the European Association for the Study of Diabetes meeting, showing weight loss figures of 4%, 4.9%, and 6.1% respectively. Roche's CT-996 led in efficacy but had high adverse event rates, while Novo's amycretin faced manufacturing challenges. Terns' TERN-601 showed potential for high efficacy and tolerability, though it requires further Phase II data.

FDA approves Eli Lilly's Ebglyss (lebrikizumab-lbkz) for moderate-to-severe atopic dermatitis, targeting IL-13 cytokine. Supported by clinical trials showing 38% clear skin and 43% itch relief after 16 weeks, with 77% and 85% maintaining results after a year. Initially rejected in 2023 due to manufacturing concerns, approval follows EU and Japan approvals.

GLP-1 receptor agonists significantly reduce cirrhosis progression and complications in patients with metabolic dysfunction-associated steatotic liver disease, according to a study in JAMA Internal Medicine. The study, based on over 16,000 patients, found a 14% reduction in cirrhosis risk and lower risks of complications and mortality. These findings suggest potential preventive treatment for cirrhosis in diabetes and MASLD patients.

Oliver Sartor interviews Jessica Jensen on radiopharmaceuticals in cancer treatment, discussing the patient-centric approach, isotope selection complexities, supply chain investment, and the potential of new isotopes. Jensen emphasizes the importance of precision medicine, cautious innovation, and the need for holistic thinking about dose delivery, expressing optimism about the future of radiopharmaceuticals with larger companies investing in the field.

FDA approves Eli Lilly's lebrikizumab, marketed as Ebglyss, for moderate-to-severe atopic dermatitis in adults and children 12+ years old. Ebglyss, a monoclonal antibody targeting IL-13, offers a once-monthly subcutaneous injection with or without topical corticosteroids. Lilly expects U.S. availability in coming weeks, supported by Phase III studies showing significant symptom relief.